mRNA-1345 Vaccine for Respiratory Syncytial Virus

Not currently recruiting at 73 trial locations

Overseen By Moderna Clinical Trials Support Center

Age: 18 - 65

Sex: Any

Trial Phase: Phase 2

Sponsor: ModernaTX, Inc.

Must not be taking: mRNA vaccines

Disqualifiers: Anaphylaxis, Drug abuse, Fever, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new vaccine, mRNA-1345, designed to protect against respiratory syncytial virus (RSV). Researchers aim to assess its safety and effectiveness when administered to pregnant women and monitor the health of their babies after birth. The study seeks participants who are 28 to 36 weeks pregnant, plan to deliver at a study-approved maternity unit, and are willing to attend all study visits. Participants will receive one of three doses of the vaccine or a placebo for comparison. This trial aims to determine if the vaccine can protect newborns from RSV through maternal vaccination. As a Phase 2 trial, it focuses on evaluating the vaccine's effectiveness in an initial, smaller group, offering participants a chance to contribute to important research.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. However, it does mention that you should not receive any mRNA or COVID-19 vaccines within 4 weeks before or after the trial's start date, and no other vaccines within 2 weeks before or after.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that mRNA-1345, a vaccine being tested for RSV (respiratory syncytial virus), is still under study to ensure its safety. Specific safety information for mRNA-1345 is not yet available. However, similar mRNA vaccines have been safely used for other illnesses and are generally well-tolerated. These vaccines might cause mild side effects like a sore arm or a slight fever, which are common with many vaccines. This trial is in an early stage, indicating that the vaccine has passed initial safety tests in small groups. More research is needed to confirm its safety in larger groups, including pregnant women and their babies. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for Respiratory Syncytial Virus (RSV), which often include supportive care like oxygen therapy and fluids, the mRNA-1345 vaccine uses a cutting-edge mRNA technology. This vaccine introduces a synthetic messenger RNA into the body, instructing cells to produce a protein that triggers an immune response against RSV. Researchers are excited about mRNA-1345 because it has the potential to provide immunity before birth, as it is administered to pregnant individuals between 28 and 36 weeks of gestation. This early intervention could offer newborns protection right from birth, which is a significant advancement over existing treatments that primarily address symptoms rather than preventing infection.

What evidence suggests that this trial's treatments could be effective for RSV?

Research has shown that the mRNA-1345 vaccine helps reduce illnesses caused by RSV, a virus that affects the lungs. In earlier studies, one dose of this vaccine did not cause any major safety problems and decreased the risk of lung disease from RSV. The vaccine was about 80% effective in preventing RSV symptoms within the first four months after vaccination. Its benefits lasted for over eight months in older adults. In this trial, participants will receive different doses of the mRNA-1345 vaccine, labeled as Dose A, Dose B, or Dose C, or a placebo. These findings suggest that mRNA-1345 could be a strong option for preventing RSV. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for pregnant women aged 18 to less than 40, who are between 28-36 weeks into their pregnancy. They must be able to attend all study visits and have had standard antenatal care. Infants born to these mothers can also participate with parental consent.

Inclusion Criteria

I plan to give birth where the study's procedures are available.

Pregnant participants have had a prenatal ultrasound at 18 weeks of pregnancy or are willing to have one if not already done.

I have been and plan to continue receiving standard pregnancy care.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Pregnant women receive a single intramuscular injection of mRNA-1345 or placebo between 28 to 36 weeks of gestation

1 week

1 visit (in-person)

Follow-up

Participants are monitored for safety and immunogenicity, including pregnancy and birth outcomes

12 months postdelivery

What Are the Treatments Tested in This Trial?

Interventions

• mRNA-1345

Trial Overview The trial is testing mRNA-1345, a new vaccine aimed at preventing respiratory syncytial virus (RSV). Pregnant women will receive either the vaccine or a placebo to assess safety and immune response in them and their newborns.

How Is the Trial Designed?

Group I: mRNA-1345 Dose C Experimental Treatment 1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose C.

Group II: mRNA-1345 Dose B Experimental Treatment 1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single IM injection of mRNA-1345 Dose B.

Group III: mRNA-1345 Dose A Experimental Treatment 1 Intervention

Participants will be vaccinated in the period from 28 weeks to 36 weeks of gestation with a single intramuscular (IM) injection of mRNA-1345 Dose A.

Group IV: Placebo Placebo Group 1 Intervention

Participants will receive single IM injection of mRNA-1345 vaccine matching placebo in the period from 28 weeks to 36 weeks of gestation.

mRNA-1345 is already approved in United States for the following indications:

Approved in United States as mRESVIA for:

• Prevention of lower respiratory tract disease caused by RSV infection in adults aged 60 years and older

Who Is Running the Clinical Trial?

ModernaTX, Inc.

Lead Sponsor

Trials

127

Recruited

66,790,000+

Dr. Stephen Hoge

ModernaTX, Inc.

Chief Medical Officer

MD from Harvard Medical School

Stéphane Bancel

ModernaTX, Inc.

Chief Executive Officer since 2011

MBA from Harvard Business School, MSc in Engineering from École Centrale Paris

Published Research Related to This Trial

The RSVPreF3 vaccine candidate was found to be safe for use in 213 healthy pregnant women, with no significant adverse events related to the vaccine or placebo reported during the study.

The vaccine effectively increased RSV-specific neutralizing antibody levels in mothers and successfully transferred these antibodies to newborns, indicating strong immunogenicity and potential protection for infants against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus Vaccine (RSVPreF3) in Mothers and Their Infants: A Phase 2 Randomized Trial. Bebia, Z., Reyes, O., Jeanfreau, R., et al.[2023]

The investigational RSV vaccine ChAd155-RSV was well-tolerated in healthy adults aged 18-45, with no dose-related toxicity or serious adverse events observed during a 1-year follow-up.

ChAd155-RSV effectively increased specific immune responses, including neutralizing antibodies and T-cell activity, indicating its potential efficacy in generating protection against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First-in-Human Randomized Study to Assess the Safety and Immunogenicity of an Investigational Respiratory Syncytial Virus (RSV) Vaccine Based on Chimpanzee-Adenovirus-155 Viral Vector-Expressing RSV Fusion, Nucleocapsid, and Antitermination Viral Proteins in Healthy Adults. Cicconi, P., Jones, C., Sarkar, E., et al.[2022]

The Ad26.RSV.preF vaccine, tested in a phase 1/2a study with 352 adults aged 60 and older, was found to be well tolerated, showing similar side effects across different regimens.

Combining Ad26.RSV.preF with RSV preF protein significantly enhanced humoral immune responses while maintaining cellular responses, suggesting this combination could be more effective in generating immunity against RSV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety, Immunogenicity, and Regimen Selection of Ad26.RSV.preF-based Vaccine Combinations: A Randomized, Double-blind, Placebo-Controlled, Phase 1/2a Study. Comeaux, CA., Bart, S., Bastian, AR., et al.[2023]

The investigational mRNA vaccine (mRNA-1777) targeting Respiratory Syncytial Virus (RSV) was found to be safe and well-tolerated in both younger (72 participants) and older adults (107 participants), with no serious adverse events reported.

The vaccine successfully triggered a strong immune response, indicated by increased levels of RSV neutralizing antibodies and other immune markers, suggesting its potential effectiveness in protecting against RSV infections.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1, randomized, placebo-controlled study to evaluate the safety and immunogenicity of an mRNA-based RSV prefusion F protein vaccine in healthy younger and older adults. Aliprantis, AO., Shaw, CA., Griffin, P., et al.[2021]

The mRNA-1345 vaccine demonstrated high efficacy, with 83.7% effectiveness in preventing RSV-associated lower respiratory tract disease with at least two symptoms, and 68.4% efficacy against RSV-associated acute respiratory disease in a study involving 35,541 older adults.

The vaccine was generally safe, with most adverse reactions being mild to moderate and transient, although there was a higher incidence of local and systemic reactions compared to the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine in Older Adults. Wilson, E., Goswami, J., Baqui, AH., et al.[2023]

Advancements in understanding the RSV surface fusion glycoprotein have led to the development of various vaccine approaches, including mRNA vaccines, which are currently showing promising results in clinical trials for preventing RSV in infants and the elderly.

The mRNA-1345 vaccine has received FDA fast-track designation for adults over 60, highlighting its potential as a safe and effective preventative measure against RSV, especially following the success of mRNA technology in COVID-19 vaccines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of mRNA vaccines against respiratory syncytial virus (RSV). Qiu, X., Xu, S., Lu, Y., et al.[2023]

The mRNA-based vaccine V172, designed to target the pre-fusion form of the RSV F glycoprotein, was found to be safe and well-tolerated in a Phase 1 clinical trial involving 112 older adults and 48 younger adults, with common side effects being mild and manageable.

V172 induced higher neutralizing antibody levels compared to a previous vaccine candidate (V171.2) and demonstrated protective effects in an animal model, suggesting it could be an effective option for preventing RSV infections in humans.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a stabilized RSV pre-fusion F mRNA vaccine: Preclinical studies and Phase 1 clinical testing in healthy adults. Nussbaum, J., Cao, X., Railkar, RA., et al.[2023]

Citations

1. nejm.org nejm.org/doi/full/10.1056/NEJMoa2307079

Efficacy and Safety of an mRNA-Based RSV PreF Vaccine ... A single dose of the mRNA-1345 vaccine resulted in no evident safety concerns and led to a lower incidence of RSV-associated lower respiratory tract disease.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11574772/

Respiratory Syncytial Virus Vaccine (mRNA) - PMC Evaluation of the efficacy of a single dose of the mResvia vaccine in preventing a first episode of RSV-associated lower respiratory tract ...

3. cdc.gov cdc.gov/rsv/hcp/vaccine-clinical-guidance/adults.html

RSV Vaccine Guidance for Adults In this trial, efficacy of a single dose of mResvia against symptomatic RSV was approximately 80% during the first 4 months following vaccination and ...

4. nature.com nature.com/articles/s41467-025-61153-x

Immune correlates analysis of mRNA-1345 RSV vaccine ... These results confirmed persistent efficacy of a single dose of mRNA-1345 over a median 8.6 months follow-up in adults aged ≥60 years.

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40988124/

Safety, Tolerability, and Immunogenicity of Revaccination ... mRNA-1345 is a respiratory syncytial virus (RSV) vaccine approved for prevention of RSV-associated lower respiratory tract disease in ...

6. medicomart.com medicomart.com/images/document/RSV%20SDS%20sheet.pdf

Safety Data Sheet Respiratory Syncytial Virus (RSV) vaccine is an mRNA vaccine against RSV. ... No data available for mRNA-1345. For another chemically ...

7. fda.gov fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert-MRESVIA_1.pdf

Package Insert - MRESVIA The safety of MRESVIA was evaluated in Study 2 (NCT06067230) in which 502 participants aged 18 through 59 years at increased risk for LRTD caused by RSV ...

8. cdc.gov cdc.gov/vaccine-safety/vaccines/rsv.html

Respiratory Syncytial Virus (RSV) Vaccine Safety RSV immunizations protect people at increased risk for severe RSV disease when used according to the approved guidelines and recommendations.

9. products.modernatx.com products.modernatx.com/mresviapro/safety

Safety Profile for mRESVIA® (Respiratory Syncytial Virus ... Evaluate the safety profile of the mRESVIA RSV vaccine, including reported local and systemic adverse reactions between mRESVIA and a placebo.

10. ema.europa.eu ema.europa.eu/en/documents/product-information/mresvia-epar-product-information_en.pdf

mRESVIA, INN-Respiratory Syncytial Virus mRNA vaccine Safety and immunogenicity data on mRESVIA are not available for immunocompromised individuals. Individuals receiving immunosuppressant therapy or patients ...